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RSS FeedPosted by Michael Wonder on 19 Oct 2016
FDA approves Genentech’s cancer immunotherapy Tecentriq (atezolizumab) for people with a specific type of metastatic lung cancer
18 October 2016 - First and only anti-PDL1 cancer immunotherapy approved by the FDA for metastatic non-small-cell lung cancer. ...
Posted by Michael Wonder on 19 Oct 2016
Where Clinton will take ObamaCare
17 October 2016 - As with HillaryCare, a single payer, national health-care system has always been the goal. ...
Posted by Michael Wonder on 18 Oct 2016
Time to reassess the cancer compendia for off-label drug coverage in oncology
18 October 2016 - Use of cancer therapies for indications not approved by the US FDA, also known as “off-label” use, ...
Posted by Michael Wonder on 18 Oct 2016
FDA accepts for review new drug application for sodium zirconium cyclosilicate for the treatment of hyperkalaemia
18 October 2016 - AstraZeneca today announced that the US FDA has accepted a complete re-submission of a new drug ...
Posted by Michael Wonder on 18 Oct 2016
The biggest pharma election risk is in California
16 October 2016 - Political risks surrounding high drug prices aren’t limited to the presidential campaign. ...
Posted by Michael Wonder on 17 Oct 2016
FDA, EMA officials: regulators must adapt to effectively regulate precision medicine
14 October 2016 - In order to effectively regulate precision medicine, regulators must adapt to alternative methods of evidence generation, ...
Posted by Michael Wonder on 17 Oct 2016
FDA awards 21 grants to stimulate product development for rare diseases
17 October 2016 - The U.S. FDA today announced that it has awarded 21 new clinical trial research grants totaling ...
Posted by Michael Wonder on 17 Oct 2016
Valeant sets price increases for some drugs
14 October 2016 - CEO says increases ‘demonstrate that we are taking our approach to responsible pricing seriously’. ...
Posted by Michael Wonder on 17 Oct 2016
FDA approves Genentech’s Lucentis (ranibizumab injection) pre-filled syringe
14 October 2016 - First anti-VEGF pre-filled syringe FDA approved to treat people with wet age-related macular degeneration and people ...
Posted by Michael Wonder on 16 Oct 2016
Bad medicine
15 October 2016 - Approving an unproven drug sets a worrying precedent. ...
Posted by Michael Wonder on 15 Oct 2016
Health care law’s beneficiaries reflect its strengths, and its faults
14 October 2016 - Cara Suzannah Latil is living proof that the Affordable Care Act works — but also of ...
Posted by Michael Wonder on 15 Oct 2016
Insurers pay more for multiple sclerosis drug because rebates don’t help, report says
13 October 2016 - Drug makers may offer rebates to payers, but health plans continue to see notable increases in ...
Posted by Michael Wonder on 13 Oct 2016
FY 2016 generic approvals by FDA: a new record under GDUFA
12 October 2016 - The US FDA published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this ...
Posted by Michael Wonder on 13 Oct 2016
FDA fast track designation and first subject dosing with lead candidate CC8464/ASP1807 for the management of neuropathic pain associated with iSFN
13 October 2016 - Chromocell Corporation and Astellas Pharma Inc. announced today that the U.S. FDA has granted fast track ...
Posted by Michael Wonder on 13 Oct 2016
Drug coupons: helping a few at the expense of everyone
12 October 2016 - When a furore erupted over the rapidly rising price of EpiPens this summer, the drugmaker Mylan ...